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Antigen tests* are rapid tests that usually produce results in 15-30 minutes. Positive results are very accurate and reliable. However, in general, antigen tests are less likely to detect the virus than PCR tests, especially when symptoms are not present. Therefore, a single negative antigen test cannot rule out infection. To be confident you do not have COVID-19, FDA recommends 2 negative antigen tests for individuals with symptoms or 3 antigen tests for those without symptoms, performed 48 hours apart. A single PCR test can be used to confirm an antigen test result.

*Self-tests, or at-home tests, are antigen tests that can be taken anywhere without having to go to a specific testing site. Read self-test package inserts thoroughly and follow the instructions closely when performing the test.

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After a positive test result, you may continue to test positive for some time. Some tests, especially PCR tests, may continue to show a positive result for up to 90 days. Reinfections can occur within 90 days, which can make it hard to know if a positive test indicates a new infection. Consider consulting a healthcare provider if you have any questions or concerns about your circumstances.

Antibody tests detect antibodies that your body makes to fight the virus that causes COVID-19. Antibody tests should never be used to diagnose a current infection with the virus that causes COVID-19. An antibody test may not show if you have a current infection, because it can take 1 to 3 weeks after the infection for your body to make antibodies. Antibody tests can be used for public health surveillance or to test for conditions associated with COVID-19.

This overview describes current information on the types of tests used to detect SARS-CoV-2 infection and their intended uses. This information is intended for use by healthcare providers, public health professionals, and those organizing and implementing testing in non-healthcare settings. Information for the general public on COVID-19 testing is also available.

Antibody (or serology) tests are used to test for the presence of antibodies from previous infection or vaccination and can aid in fulfilling the case definition for multisystem inflammatory syndrome in children (MIS-C) and adults (MIS-A)2. Antibody testing does not diagnose current infection. Antibody testing is primarily used for public health surveillance and epidemiologic purposes. Antibody tests detect specific antibodies that target different parts (nucleocapsid or spike protein) of the virus. Detection of anti-nucleocapsid antibody indicates SARS-CoV-2 infection, while anti-spike protein antibody may be induced by COVID-19 vaccination or by SARS-CoV-2 infection. This should be considered when choosing whether to test for antibodies originating from past infection versus those from vaccination.

Diagnostic testing is intended to identify current infection. It is performed when a person has signs or symptoms consistent with COVID-19 or is asymptomatic but has recent known or suspected exposure to someone with COVID-19.

Screening testing is intended to identify people with COVID-19 who are asymptomatic or do not have any known, suspected, or reported exposure to someone with COVID-19.

Table 1 summarizes some characteristics of NAATs and antigen tests to consider for a testing program. Laboratories that perform screening or diagnostic testing for SARS-CoV-2 must have a CLIA certificate and meet regulatory requirements. Tests that have received an EUA from FDA for point-of-care (POC) use can be performed with a CLIA certificate of waiver.

The main effect of vaccination on SARS-CoV-2 testing is related to antibody testing. Because mRNA COVID-19 vaccines use the SARS-CoV-2 spike protein to generate an immune response, a positive serologic (antibody) test for spike protein IgM/IgG could indicate either previous infection or vaccination.

To evaluate for evidence of previous infection in a vaccinated individual, use an antibody test specifically evaluating IgM/IgG to the nucleocapsid protein. For example, specific antibody tests can be used for public health surveillance.

Social determinants of health may influence access to testing. For example, travel time may limit access to, and use of, testing services for those who have limited access to transportation and who live in areas with fewer public transit services and schedules. Racial and ethnic disparities in test site distribution have been found.3 Other factors that may affect both access to, and use of, testing services include:

Positive test results using a viral test (NAAT, antigen or other tests) in individuals with signs or symptoms consistent with COVID-19 indicate that the person has COVID-19. A negative antigen test in individuals with signs or symptoms of COVID-19 should be repeated following FDA recommendations or confirmed by NAAT. For more information, see Antigen Test Algorithm.

Additionally, consider other illnesses with similar symptoms that may require testing. For many diseases, including flu, early diagnosis and prompt treatment is very important for preventing severe illness.

Viral Testing is recommended for individuals who have been exposed to someone with COVID-19. People who have had an exposure to someone known or suspected of having COVID-19 should be tested at least 5 days after the exposure. If symptoms develop before 5 days, they should get tested immediately.

If someone has had exposure to someone with COVID-19 and is asymptomatic, but has had COVID-19 within the past 30 days*, testing to identify a new infection is generally not recommended. If someone has become newly symptomatic after having had COVID-19 within the past 30 days*, antigen tests should be used to identify a new infection. If they test negative, they should repeat the antigen test following FDA recommendations.

If someone had exposure to another person with COVID-19, but the exposed individual has had COVID-19 within the past 31-90 days*, consider using antigen tests (rather than an NAAT, such as a PCR test) to identify a new infection. They should get tested at least 5 full days after their exposure. If they test negative with an antigen test, they should repeat the antigen test following FDA recommendations.

Some adults with severe illness or who are moderately or severely immunocompromised may produce replication-competent virus beyond 10 days that may warrant extending duration of isolation and precautions. A test-based strategy for ending isolation in these patients may be considered in consultation with infectious disease experts. For more information, including on retesting people previously infected with SARS-CoV-2, visit Ending Isolation and Precautions for People with COVID-19: Interim Guidance.

Screening testing allows early identification and isolation of people who are asymptomatic or pre-symptomatic and who might be unknowingly transmitting virus. Screening testing may be most valuable in specific settings where early identification is essential to reducing transmission and mitigating risk for severe disease among populations at high risk. When COVID-19 hospital admission levels are high, CDC recommends implementing screening testing in certain high-risk settings.

Any type of viral test can be used for screening purposes; however, consider the characteristics (including accessibility, accuracy and efficiency) of different test types to determine which best suits screening testing needs.

Settings that should be prioritized for screening testing include facilities and situations where transmission risk is high and the population served is at high risk of severe outcomes from COVID-19 or there is limited access to healthcare, including:

Public health surveillance testing may sample a certain percentage of a specific population to monitor for increasing or decreasing infection rate or to determine the population effect from community interventions. An example of public health surveillance testing is when a state public health department samples a random percentage of all people in a city on a rolling basis to assess local infection rates and trends.

The European Institute for Computer Antivirus Research (EICAR) has developed a test virus to test your antivirus appliance. This script is an inert text file. The binary pattern is included in the virus pattern file from most antivirus vendors. The test virus is not a virus and does not contain any program code.

COVID-19 testing plays a critical role in the fight against the virus. Understanding COVID-19 tests, including the different types of tests and their uses, and the types of samples the tests use, is key to making an informed decision that meets your needs.

If you think you need a COVID-19 diagnostic test, you can find a community testing site in your state. You can also use an FDA-authorized at-home COVID-19 diagnostic test which gives you the option of self-testing where it is convenient for you. Be sure to check the At-Home OTC COVID-19 Diagnostic Tests website for information on expiration dates, who can use the test, and other details that may help you decide what test is right for you. Be aware that COVID-19 diagnostic tests are authorized for specific uses and that laboratory-based molecular COVID-19 tests, are generally more accurate than at-home tests.

To increase the accuracy of an at-home COVID-19 antigen diagnostic test, it is important to perform repeat testing, after 48 hours, following a negative test result, whether you have symptoms or not, to reduce your risk of a false negative test result. For more information about how to reduce your risk of getting a false negative result on an at-home COVID-19 antigen test, read our FDA Safety Communication. For additional information on reading and understanding your test results, see Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results.

For details about each authorized COVID-19 diagnostic test, see the lists of authorized Molecular Diagnostic Tests and Antigen Diagnostic Tests, as well as the At-Home COVID-19 Diagnostic Tests webpage. Using the search box in the EUA tables, you can use keywords to search and filter the type of test or collection kit you are looking for. As new tests are authorized for use, they are added to these tables so that anyone can access up-to-date information on all authorized tests and collection kits. 2351a5e196